Multiple MyelomaNCT06151717
A Comparative Clinical Study to Determine the Optimal Initial Therapy for Multiple Myeloma
An observational study of Multiple Myeloma, run by Mayo Clinic at 4 sites in United States.
Trial summary
This study evaluates the outcomes of patients undergoing initial therapy for multiple myeloma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Non-Interventional Study
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Sep 2023to 5 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with previously untreated multiple myeloma
Who may be able to join
- Previously untreated active multiple myeloma starting a new treatment for the disease with one of the three established treatment regimens: VRd (bortezomib, lenalidomide, dexamethasone), DRd (daratumumab lenalidomide dexamethasone), or DVRd (daratumumab, bortezomib, lenalidomide, and dexamethasone)
- No prior treatment for myeloma
- Not receiving concurrent treatment for another active malignancy
- No more than 3 months from start of treatment
Who cannot join
- Does not meet all inclusion criteria
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: PRAGMMATIC: A Comparative Clinical Trial to Determine the BEST Initial Therapy for Multiple Myeloma
This study evaluates the outcomes of patients undergoing initial therapy for multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVE:
- Compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed MM.
OUTLINE: This is an observational study.
Patients have their medical records reviewed on study.
- Conditions
- Multiple Myeloma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival, defined as the time from initiation of therapy to the time of death due to any cause, will be assessed by review of medical record, contacting the participant, or contacting the participant's local physician every 3 months for up to 10 years after participant starts the study.
Measured: Every 3 months, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start21 Sep 2023
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaji K. Kumar, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151717
- Sponsor's protocol ID
- MC230811
- Other IDs
- NCI-2023-09520, MC230811, PRAGMMATIC, 23-006335
- Status last verified
- Jun 2025
- First submitted
- 22 Nov 2023
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRAGMMATIC: A Comparative Clinical Trial to Determine the BEST Initial Therapy for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06151717
- Acronym / sponsor ID
- MC230811
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the outcomes of patients undergoing initial therapy for multiple myeloma.
Detailed description
PRIMARY OBJECTIVE:
- Compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed MM.
OUTLINE: This is an observational study.
Patients have their medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients have their medical records reviewed on study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with previously untreated multiple myeloma
Key inclusion criteria (4 listed)
- Previously untreated active multiple myeloma starting a new treatment for the disease with one of the three established treatment regimens: VRd (bortezomib, lenalidomide, dexamethasone), DRd (daratumumab lenalidomide dexamethasone), or DVRd (daratumumab, bortezomib, lenalidomide, and dexamethasone)
- No prior treatment for myeloma
- Not receiving concurrent treatment for another active malignancy
- No more than 3 months from start of treatment
Key exclusion criteria (1 listed)
- Does not meet all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Overall survival
Time frame: Every 3 months, up to 10 years
Overall survival, defined as the time from initiation of therapy to the time of death due to any cause, will be assessed by review of medical record, contacting the participant, or contacting the participant's local physician every 3 months for up to 10 years after participant starts the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaji K. Kumar, MD principal investigator
Mayo Clinic in Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Mayo Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Every 3 months, up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025; AzTrials last refreshed its copy on 2 Nov 2026.